Field of the Invention
The present invention relates to an artificial tears solution combination, and in particular to an artificial tear solution combination capable of keeping moisture, and at the same time having anti-inflammation and anti-oxidation capabilities, and that is used to treat moderate dry eye syndrome (DES) with ocular surface inflammation.
The Prior Arts
It is well known that, having healthy eyes and good vision to see things clearly is important for daily life. Nowadays, since most of the people keep fast-paced life styles and busy working schedules, they tend to neglect to take care of their eyes. In addition, due to various risk factors, such as staying in an air-conditioned room; watching TV, computer screen, or long-time wearing contact lenses, thus tend to leading various eye diseases, and in this respect, the dry eye syndrome is a very common eye disease in clinic nowadays.
The DES can be categorized into three stages due to its clinical symptoms: mild, moderate, and severe.
The treatment of the dry eye syndrome can be varied depending on severity of the symptoms. At present, there are three kinds of treatments as follows:
1. Mild: usually artificial tears solution is used to relieve the dryness of eyes. Sometimes, eye ointment is utilized as a treatment.
2. Moderate: In this stage, DES with inflammation on ocular surface is found. Anti-inflammatory eye ointment and artificial tears solution are used concurrently for treatment. Also, incursion surgery such as tear drops blockage operation, that can reduce loss of tear drops, is adopted to relieve eye dryness.
3. Severe: In this stage, only eyelid suture operation or saliva gland transplantation can be adapted to increase tear production for relieving the eyes from dryness.
Further, for a healthy eye under fluorescein staining, the ocular surface, especially cornea, is transparent. However, for a person having DES thus causing cornea epithelium damage, his/her eyes under fluorescein staining test tend to be blurred and spotted due to staining on the impaired cells.
Refer to Table 1 for contains of artificial tears solution presently available on the market.
TABLE 1contains of artificial tears solution available on the market.ManufacturerContentsHYPO TEARS LUBRICATINGPolyvinyl AlcoholEYE DROPSMEDICINE Hi Tears 1.4%Polyvinyl Alcohol(artificial tears solution)Dearen Artificial TearsPotassium Chloride“Wantanabe”Sodium Chloride(eq to DISOD. Hydrogen Phosphate)(eq to Disodium Phosphate)Sodium Carbonate AnhydrousSynpac-KingdomHydroxypropylmethyl Cellulose(artificial tears solution)(eq to Hypromell Osehydromellose)(HPMC)NEW I TEN RIN artificial tearsPotassium ChloridesolutionSodium ChlorideNEW I TEN RIN artificial tearsDextran 70solution lubricantGlycerin (eq to Glycerol)
In this respect, Epigallocatechin gallate (EGCG) is the most abundant component in the Catechin of green tea, it has been proved as having anti-inflammation and anti-oxidation effect. Therefore, it is capable of suppressing multiple inflammation factors (Megan E. Cavet, et al., Molecular Vision Biology and Genetics in Vision Research, 2011 February, 17: 533-543).
Hyaluronic acid (HA) is a natural biological substance, and is a kind of extracellular matrix. According to the research report, it plays an important role in wound healing and inflammation processing (MInoue and C Katakami, Investigative Ophthalmology & Visual Science, 1993 June, 34(7):2313-2315). Besides, it is usually utilized in treating eye dryness. The reason for this is that, H A is able to increase the viscosity of solution, to prolong the time of solution staying on the ocular surface (Papa V, Aragona P. Russo S. et al. Ophthalmologica 2001; 215:124-7, Stern M E, Beuerman R W, Fox R I, et al. Cornea 1998; 17:548-9, Mengher L S, Pandher K S, Bron A J, et al. Br J Ophthalmol 1986; 70: 422-7). In the following, refer to Table 2 for the artificial tears solution containing Hyaluronic acid (HA) as presently available on the market.
TABLE 2the artificial tears solution containingHyaluronic acid (HA) supplement on the market.Artificial tears solutionhaving HAas available on marketcontentsCIBA contact lensSodium Chloriderelief solutionSodium PerborateHyaluronate Sodium(eq to Sodium Hyaluronate)Sodium Phosphate Dibasic Anhydrous(eq to Disodium Hydrogen Phosphate Anhydrous)(eq to Dibasic Sodium Phosphate Anhydrous)(Disodium Phosphate Anhydrous)Sodium Phosphate Monobasic Monohydrate(Sodium Dihydrogen Phosphate Monohydrate)Dequest 2060“Kingdom” contactSodium Chloridelens reliefSodium PerboratesolutionHyaluronate Sodium(eq to Sodium Hyaluronate)Sodium Phosphate Dibasic(eq to DISOD. Hydrogen Phosphate)(eq to Disodium phosphate)Sodium Phosphate Monobasic Monohydrate(Sodium Dihydrogen Phosphate Monohydrate)Water Distilled(eq to Distilled Water)Dequest 2060VISMED contact lensSodium Citrate (Sodium Citrate Tribasic)relief solutionCalcium Chloride DihydrateMagnesium Chloride Hexahydrate(eq to Magnesium Chloride 6H2O)Potassium ChlorideSodium ChlorideHyaluronate Sodium(eq to Sodium Hyaluronate)Sodium Phosphate Dibasic Dodecahydrate(eq to Disodium phosphate Dodecahydrate)Wather for Injection
However, as shown in Tables 1 and 2, for the contains of the artificial tears solutions presently available on the market, most of them are buffer solution of salts without adding recipe for treating inflammation, such that its function is restricted only to provide moisture for relieving dryness of eyes. Moreover, a part of artificial tears solutions presently available on the market contains preservatives, thus leading to worsen the dry eye syndrome (Ankita S. Bhaysar, et al., Oman J Ophthalmol. 2011 May-August; 4(2):50-56).
Presently, for the treatment of moderate eye dryness syndrome, ophthalmologists often prescribe eye ointment, liquid medicine (eye drop), artificial tears solution or anti-inflammation agents for treat DES separately, and usually use multi-agents in order. However, due to the busy life style, people has no patience for take multi-agents and usually only take one agent and forget to take other agents, thus leading to effective-less therapy and prolonging treatment period. In addition, the applying of ointment could cause blurring of vision of patients, hereby resulting in inconvenience of patient's activity.
Further, after being dipped onto the ocular surface for about 5 minutes, the artificial tears solution or liquid agents (eye drops) tend to not remain on the ocular surface, due to evaporation or the nasolacrimal duct drainage, thus causing poor ocular drug bioavailability. For this reason, in prescribing eye drops, ophthalmologists usually advise patients to apply it 3 to 4 times per day, and after applying one eye drop for 5 minutes, then can dipping another one. However, for a patient who suffered multi-agents therapy, he/she needs separately and repeatedly dropping many lead to inconvenience to the patient, thus adversely affecting the therapeutic outcome.
Therefore, presently, the preparation and performance of artificial tears solution is not quite satisfactory, and it has some methods to improve the therapeutic effect of artificial tear solution for DES treatment.